EP3911217A1 - Ensemble capteur en deux parties et procédé d'utilisation - Google Patents

Ensemble capteur en deux parties et procédé d'utilisation

Info

Publication number
EP3911217A1
EP3911217A1 EP19910336.7A EP19910336A EP3911217A1 EP 3911217 A1 EP3911217 A1 EP 3911217A1 EP 19910336 A EP19910336 A EP 19910336A EP 3911217 A1 EP3911217 A1 EP 3911217A1
Authority
EP
European Patent Office
Prior art keywords
attachment collar
sensor
sensor assembly
skin
piece
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19910336.7A
Other languages
German (de)
English (en)
Other versions
EP3911217A4 (fr
Inventor
Anthony Le
Martin Leugers
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medibeacon Inc
Original Assignee
Medibeacon Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medibeacon Inc filed Critical Medibeacon Inc
Publication of EP3911217A1 publication Critical patent/EP3911217A1/fr
Publication of EP3911217A4 publication Critical patent/EP3911217A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/201—Assessing renal or kidney functions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6835—Supports or holders, e.g., articulated arms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6843—Monitoring or controlling sensor contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0021—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent group being a small organic molecule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D241/00—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings
    • C07D241/02—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings
    • C07D241/10—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings having three double bonds between ring members or between ring members and non-ring members
    • C07D241/14—Heterocyclic compounds containing 1,4-diazine or hydrogenated 1,4-diazine rings not condensed with other rings having three double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D241/24—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
    • C07D241/26—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with nitrogen atoms directly attached to ring carbon atoms
    • C07D241/28—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with nitrogen atoms directly attached to ring carbon atoms in which said hetero-bound carbon atoms have double bonds to oxygen, sulfur or nitrogen atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
    • A61B2562/222—Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables

Definitions

  • the field of the disclosure relates generally to sensor systems. More specifically, this disclosure generally relates to a two-piece sensor assembly where the skin sensor that comprises the complex electronic components is reusable and the attachment collar that holds the skin sensor in place on the body of a patient is either disposable or reusable.
  • the glomerular filtration rate is an important clinical parameter to assess the level of kidney function in a patient. As shown in the table below, the lower the GFR, the more serious the kidney impairment for Chronic Kidney Disease (CKD) and other renal insufficiencies.
  • the GFR can be estimated based on a blood test measuring the blood creatinine level in the patient in combination with other factors. More accurate methods involve the injection of an exogenous substance into a patient followed by careful monitoring of plasma and/or urine concentration over a period of time. These are often contrast agents (CA) that can cause renal problems on their own. Radioisotopes or iodinated aromatic rings are two common categories of CAs that are used for GFR determination.
  • CA contrast agents
  • Increase of risk factors e.g., diabetes, high blood > 90
  • GFR is measured in units of mL/min/1.73m 2 .
  • GFR agents examples of exogenous substances capable of clearing the kidney exclusively via glomerular filtration
  • examples of exogenous substances capable of clearing the kidney exclusively via glomerular filtration include creatinine, oiodohippuran, and " m Tc-DTPA.
  • examples of exogenous substances that are capable of undergoing renal clearance via tubular secretion include " m Tc-MAG3 and other substances known in the art.
  • m Tc-MAG3 is also widely used to assess renal function though gamma scintigraphy as well as through renal blood flow measurement.
  • the sensor assembly generally comprises: an attachment collar configured to attach to a body surface of a patient and comprising at least one opening, and a skin sensor configured to seat into the at least one opening in the attachment collar.
  • the skin sensor generally comprises: at least one radiation source configured to irradiate the body surface with at least one interrogation light, and at least one detector configured to detect at least one response light incident from the direction of the body surface.
  • a method for determining a glomerular filtration rate (GFR) in a patient in need thereof generally comprises:
  • a two-piece sensor assembly onto the body surface of the patient, administering into the body of the patient an indicator substance, said indicator substance configured to generate an optical response in response to an interrogation light; detecting said optical response using the two-piece sensor assembly over a predetermined period of time; and determining the GFR in said patient based on the detected optical response.
  • Figure 1 illustrates one embodiment of the two-piece sensor assembly that includes a locking bar on each side of the sensor to secure it to the attachment collar, a cord management system to provide strain relief and security from cord pulls, and a pull tab for easy removal of the attachment collar from skin.
  • Figure 2 illustrates one embodiment of the two-piece sensor assembly for attaching the skin sensor to the attachment collar using selectively adhesive surfaces.
  • Figure 3 illustrates one embodiment of the two-piece sensor that includes a bar code/QR reader.
  • Figure 4 illustrates a torturous light path for the connection between the skin sensor and the attachment collar to ensure a light-tight fit.
  • Figure 5 illustrates a cam lock between the skin sensor and the attachment collar.
  • Figure 6 illustrates one embodiment of the two-piece sensor assembly that comprises tabs to aid the alignment and positioning of the skin sensor relative to the attachment collar.
  • Figure 7 illustrates a stretch pocket attachment collar for the two-piece sensor assembly that provides a slight downward pressure to the skin sensor onto the skin of the patient.
  • Figure 8 illustrates one embodiment of the two-piece sensor assembly that includes RFID authentication and grooves within the attachment collar for the cord to provide security from cord pulls.
  • Figure 9 illustrates one embodiment of the two-piece sensor assembly that includes a lock and key type security feature between the attachment collar and the skin sensor.
  • Figure 10 illustrates one embodiment of the two-piece sensor assembly that includes a magnetic connection between the attachment collar and the skin sensor.
  • Figure 11 illustrates one embodiment of the two-piece sensor assembly that includes an attachment collar that encircles the sensor, and a cable management system to provide strain relief and security from cord pulls.
  • Figure 12 illustrates one embodiment of the two-piece sensor assembly that includes an embedded chemical in the attachment collar that can be detected by the sensor.
  • Figure 13 illustrates one embodiment of the two-piece sensor assembly that includes a swivel attachment between the skin sensor and the attachment collar.
  • Figure 14 illustrates one embodiment of the two-piece sensor assembly that includes a tab placement port and cord management system to provide strain relief and security from cord pulls.
  • Figure 15 illustrates one embodiment of the two-piece sensor assembly that includes fold-over tabs to secure the skin sensor to the attachment collar.
  • Figure 16 illustrates one embodiment of the two-piece sensor assembly that includes a communication port (e.g., an EEPROM) between the skin sensor and the attachment collar.
  • a communication port e.g., an EEPROM
  • Figure 17 illustrates one embodiment of the two-piece sensor assembly that includes a cam lock to secure the skin sensor to the attachment collar, and providing a slight downward pressure to the skin sensor onto the skin of the patient and visual indication that the sensor is locked in place.
  • Figure 18 illustrates one embodiment of the two-piece sensor assembly that includes a wrap mechanism to secure the skin sensor to the attachment collar, and providing a slight downward pressure to ensure a light-tight fit.
  • Figure 19 illustrates one embodiment of the two-piece sensor assembly that includes clips on the skin sensor which secure the sensor to the attachment collar, a cord management system to provide strain relief and security from cord pulls, and a pull tab for easy removal of the attachment collar from the skin when the session is complete.
  • Figure 20 illustrates one embodiment of the two-piece sensor assembly that includes a locking mechanism on the skin sensor which secures the sensor to the attachment collar, a cord management system to provide strain relief and security from cord pulls, and a pull tab for easy removal of the attachment collar from the skin when the session is complete.
  • Figure 21 illustrates one embodiment of the two-piece sensor assembly that includes an attachment collar that encircles the sensor to ensure a light-tight fit, a cord management system to provide strain relief and security from cord pulls, and a pull tab for easy removal of the attachment collar from the skin when the session is complete.
  • Figure 22 illustrates one embodiment of the two-piece sensor assembly that includes clips on the skin sensor which secure the sensor to the attachment collar, a cord management system to provide strain relief and security from cord pulls, and a pull tab for easy removal of the attachment collar from the skin when the session is complete.
  • the drawings and figures provided herein illustrate features of embodiments of the disclosure or results of representative experiments illustrating some aspects of the subject matter disclosed herein. These features and/or results are believed to be applicable in a wide variety of systems including one or more embodiments of the disclosure. As such, the drawings are not intended to include all additional features known by those of ordinary skill in the art to be required for the practice of the embodiments, nor are they intended to be limiting as to possible uses of the methods disclosed herein.
  • Approximating language may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as“about,”“approximately,” and“substantially,” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value.
  • range limitations may be combined and/or interchanged; such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise.
  • the term“light-tight” means the interface between two surfaces does not permit the passage of external light.
  • a surface of the skin sensor faces the body surface.
  • No external light penetrates to the body surface between the interface of the skin sensor and the attachment collar to reach the area of the body surface that faces the skin sensor.
  • no external light passes between the body surface of the patient and the surface or edges of the attachment collar adhered to or in contact with the body surface.
  • the only light detected by the skin sensor emanates directly incident to the body surface of the patient.
  • the only light detected by the skin sensor emanates from a response light generated by an indicator substance inside the body of the patient.
  • PCT/EP2009/060785 which is incorporated by reference herein in its entirety for all purposes, discloses skin sensors that can, in some aspects, be configured for use in conjunction with an attachment collar thereby creating a two-piece sensor assembly as disclosed herein.
  • the term "patient” as used herein refers to a warm blooded animal such as a mammal which is the subject of a medical treatment for a medical condition that causes at least one symptom. It is understood that at least humans, dogs, cats, and horses are within the scope of the meaning of the term. In some aspects, the patient is human. As used herein, any suitable surface on the body of the patient may be used as the body surface. Examples include, but are not limited to, skin surfaces, fingernails or toenails, more particularly surfaces exposed to the atmosphere. Generally, as used herein, the term “patient” means a human or an animal on which at least one of the two-piece sensor assembly may be used, independently of the health of the patient.
  • the skin sensor comprises at least one radiation source.
  • a radiation source is understood to be any device which can emit radiation anywhere on the electromagnetic spectrum.
  • the electromagnetic radiation is in the visible, infrared, ultraviolet, and/or gamma spectral range.
  • other types of radiation can also be used, for example streams of particles.
  • alpha rays and/or beta rays may be used.
  • the radiation source is configured to generate radiation of the type mentioned. Without restricting the type of radiation used and for convenience only, hereinafter radiation is generally designated as“light” whether or not it is in the visible region of the electromagnetic spectrum, and the radiation source is described more particularly with reference to a“light source”.
  • other radiation source is described more particularly with reference to a“light source”.
  • configurations of the radiation source are possible, in some aspects, and it is also possible, in some aspects, to combine different types of radiation sources.
  • the radiation source can be, for example, an integral constituent of the skin sensor, for example in the context of a layer construction of the skin sensor.
  • the radiation source is therefore designed to generate at least one interrogation light directly within the skin sensor, in contrast to external generation of the interrogation light.
  • the skin sensor differs, for example, from the fiber-optic construction in US 6995019 B2, in which an external light source is used.
  • an individual light source in some aspects, it is also possible to use a plurality of light sources, for example redundant light sources for emitting one and the same wavelength, and/or a plurality of different light sources for emitting different wavelengths.
  • the at least one light source is designed to irradiate the body surface with at least one interrogation light.
  • An interrogation light is understood to be a light that can be used for the detection of an indicator substance as disclosed elsewhere herein, whose light excites the indicator substance inside a body tissue and/or a body fluid of the patient, for example with variable penetration depth, and causing a perceptible response, more particularly, an optically perceptible response.
  • This excitation takes place in such a way that a luminescence, a fluorescence and/or a phosphorescence is initiated in the indicator substance.
  • other types of excitation occur, for example scattering of the light at an identical or shifted wavelength.
  • at least one response light is generated by the indicator substance in response to the interrogation light.
  • the interrogation light is designed such that the desired response is excited in a targeted manner in the indicator substance. Accordingly, by way of example and not limitation, a wavelength and/or a wavelength range of the interrogation light and/or some other property of the interrogation light can be adapted or adjusted based on the identity and properties of the indicator substance. This can be done directly by the radiation source, for example, by virtue of the radiation source providing the interrogation light having a specific wavelength and/or in a specified wavelength range and/or by the inclusion of at least one excitation filter being used to filter out the desired interrogation light from a primary light of the light source.
  • the skin sensor performs fluorescence measurements on the indicator substance. Accordingly, the interrogation light can be adapted to the excitation range of the fluorescence of the indicator substance.
  • the skin sensor further comprises at least one detector designed to detect at least one response light incident from the direction of the body surface.
  • the response light can be light in the sense of the above definition.
  • the detector is also an integral constituent of the skin sensor. The detector is therefore part of the skin sensor such that the response light is detected directly within the skin sensor, in contrast, for example, to the fiber-optic construction in US 6995019 B2, in which an external detector is required.
  • the response light represents an optical response of the indicator substance to the incidence of the interrogation light.
  • the detector and/or the detector in interaction with at least one response filter is configured to detect in a targeted manner in the spectral range of the response light.
  • the detector and/or the detector in interaction with the at least one response filter is configured to suppress light outside the spectral range of the response light.
  • the detector and/or the detector in interaction with the at least one response filter can be designed to suppress the interrogation light.
  • response filters are designed to suppress the detection of ambient light, particularly at wavelengths that can travel long distances in tissue prior to absorption, such as a spectral range of from about 700 to about 1100 nm.
  • the interrogation light and the response light can be configured such that they are spectrally different or spectrally shifted relative to one another with regard to their spectral intensity distribution.
  • the response light shifts toward longer wavelengths in comparison with the interrogation light, which generally occurs in a fluorescence measurement (i.e., the Stokes shift).
  • the Stokes shift of a peak wavelength of the response light relative to a peak wavelength of the interrogation light is between about 10 nm and about 200 nm, more particularly between about 100 nm and about 150 nm, and particularly about 120 nm.
  • the detector and/or the detector in interaction with the at least one response filter can be designed to detect such response light. About in this context means ⁇ 10 nm.
  • the at least one radiation source more particularly, the at least one light source, and the at least one detector are designed to irradiate the body surface with the
  • the radiation source and the detector are therefore optically connected to the body surface in such a way that, through the body surface, for example transcutaneously, the interrogation light can be radiated into the body tissue or the body fluid of the patient, and that, likewise through the body surface, for example transcutaneously, the response light from the body tissue or the body fluid is observed by the detector.
  • the sensor assembly may comprise further elements.
  • the attachment collar comprises further elements.
  • the skin sensor comprises further elements.
  • both the skin sensor and the attachment collar comprise further elements.
  • the skin sensor can comprise, for example, at least one interface for data exchange.
  • Said data can be, for example, measurement results for intensities of the response light detected by the detector.
  • Data already partly processed, filtered or partly or completely evaluated data can also be transmitted via said interface.
  • the interface can be configured as a wireless interface, a cabled interface or a combination thereof, and can comprise a radiofrequency coil and/or a cable.
  • transponder technology known in the art may be used, for example, to initiate a measurement via the skin sensor and/or to interrogate measurement data from the skin sensor.
  • corresponding radiofrequency readers such as are known from RFID technology (radiofrequency identification label technology), for example, can be used for this purpose.
  • the two-piece sensor assembly further comprises a controller.
  • the controller is programmed to control the at least one skin sensor comprising the at least one radiation source and the at least one detector.
  • the controller is further programmed to receive authentication information from the skin sensor, the attachment collar or both.
  • the authentication information can be using techniques known in the art such as, for example, EPROM or RFID.
  • the connection between the controller and the skin sensor is cabled, wireless or a combination thereof.
  • the connection between the controller and the other components is by a cable.
  • the connection between the controller and the other components is wireless.
  • the controller is contained within the sensor.
  • the sensor assembly can comprise at least one driving or controlling electronic unit.
  • Said driving electronic or controlling unit can be configured, for example, for driving or controlling the at least one radiation source and the at least one detector, for example, for starting an emission of the interrogation light and/or for initiating a detection of the response light.
  • the driving or controlling electronic unit can comprise, for example, corresponding drivers for the detector and/or the radiation source.
  • a timing for a measurement can also be predefined, such that, for example, the driving or controlling electronic unit can predefine a specific time scheme for the light source and/or the detector, said time scheme allowing a temporal sequence of the emission of the interrogation light and the detection of the response light.
  • the driving electronic unit can be designed to carry out or to control a temporally resolved measurement of the skin sensor.
  • a measurement comprises the emissions of at least one interrogation light, more particularly of at least one pulse of the interrogation light, and the detection of at least one response light, more particularly of at least one pulse of the response light.
  • a temporally resolved measurement can accordingly be understood to be a measurement in which, in addition, a time of the detection of the response light also plays a part or is registered.
  • a time of the detection of the response light also plays a part or is registered.
  • the detector is configured to detect the different time points generated by the interaction of an indicator substance with a light generated by the light source.
  • the controller and the driving or controlling electronic unit are the same device.
  • the driving and controlling electronic unit is an integrated component in the controller.
  • the light source is modulated rather than pulsed, and the detected signal is selectively amplified or digitally demodulated to selectively detect signals at the frequency of the source.
  • the two-piece sensor assembly further comprises a cable management system configured to reduce or eliminate accidental cord pulls that would dislodge or detach the two-piece sensor assembly from the body of the patient and/or reduce or eliminate accidental cord pulls that would dislodge or detach the skin sensor from the attachment collar, said cable management system is attached to the attachment collar, the skin sensor or both.
  • one or both are fabricated out of elastomeric materials.
  • the elastomer is mixed with graphite and/or carbon black and/or other light-absorbing materials.
  • an optically non-transmissive material is included as a layer. In some aspects, the optically non-transmissive material is mylar.
  • Mylar is highly absorptive of UV, visible and near infrared light while also being thin and flexible.
  • the optically non-transmissive material is aluminum.
  • Aluminum is also highly absorptive of UV, visible and near infrared light while also being thin and flexible. This reduces light transmission through the skin sensor and/or attachment collar.
  • both the skin sensor and the attachment collar are fabricated from an elastomer that is mixed with graphite, carbon black or a combination thereof.
  • a optically non-transmissive material is one that reduces or eliminates the passage of light therethrough. In some aspects, the passage of light is entirely eliminated. In some aspects, the passage of light is reduced by about 99%, by about 98%, by about 97%, by about 96%, by about 95%, or by about 90%. About as used in this context means ⁇ 1%.
  • the attachment collar is disposable.
  • the skin sensor and attachment collar are designed to ameliorate the effects of accumulation of excess fluid within the skin of the patient beneath the sensor, which could otherwise have detrimental or undesirable effects on the sensor measurements.
  • variation over time in the fractional volume of interstitial fluid within the measured tissue volume may result in uncertainty and/or inaccuracy in the transdermally measured elimination rate.
  • fluid over-load such as is common in patients with, for example, compromised kidney function or congestive heart failure.
  • Such excess fluid may be removed from the field of measurement by the application of light pressure against the skin (e.g., 10-20 mm Hg), without exsanguinating the skin or shifting the balance of more tightly bound interstitial fluid.
  • a positive pressure is exerted on the surface of the skin directly beneath the skin sensor, while simultaneously applying a negative pressure on the surrounding skin surface, beneath which the attachment collar is mounted. In some aspects, this is accomplished by first securely mounting the attachment collar to the skin, then mounting the skin sensor into the collar such that the sensor protrudes slightly beyond the collar, thereby pressing more firmly against the skin beneath the sensor, with a compensating negative pressure in the area beneath the attachment collar.
  • a 2-sided adhesive is employed within an aperture inside the attachment collar.
  • the side facing the skin is selected to adhere reliably to the skin for an extended period of time (e.g., 24 to 48 hrs.), even in the presence of moisture, such as sweat.
  • an acrylate-based adhesive is used for bonding to the skin.
  • the skin is pre-treated with a barrier film, such as by application of rapidly- drying liquid film that upon drying forms a“second skin”. In such aspects the barrier film aids in the long-term, reliable attachment of the acrylate-based adhesive to the skin, while also having the benefit of allowing sensor removal without disruption or removal of the skin epidermis.
  • the barrier film is CAVILONTM (manufactured by 3M).
  • the second side of the adhesive, which faces towards the sensor, may be selected to adhere as strongly as desired to the face of the sensor.
  • the sensor face is constructed from a polymer material, such as MAKROLONTM, and the adhesive is rubber based.
  • One non-limiting example of an appropriate 2-sided adhesive is 3M product # 2477 (Double-Coated TPE Silicone Acrylate Medical Tape with Premium Liner).
  • the adhesive bond formed between the attachment collar and sensor is relatively weak or even non-existent until the adhesive is placed under mild pressure.
  • Such embodiments have the additional benefit of forming a secure interface between the sensor and the skin when the sensor is placed under positive pressure against the skin, but once released, the sensor is easily removed from the attachment collar without leaving a residue on the sensor.
  • the sensor portion never contacts the skin. If the sensor does not come into direct contact with the skin of the patient, this reduces the chance of contamination and reduces the cleaning and/or sterilization needed before the sensor is reused on the same or a different patient.
  • the collar includes an encrypted identifier or identification tag that prevents the use on non-approved devices.
  • the encryption code is embedded in an EEPROM chip within the attachment collar. Use of the sensor is prevented unless a connection is made between the sensor and collar, and the collar is identified as being valid.
  • the EEPROM is used to identify a particular product version, mode of operation, and/or algorithm coefficients for instrument operation. In this manner, different functions of the sensor may be enabled through the EEPROM coding.
  • the attachment collar further comprises a pressure sensitive element that communicates with the sensor when attached.
  • the pressure sensor provides an indication of secure attachment of the skin sensor to the skin of the patient.
  • the indication that the sensor is no longer securely attached is used to discontinue measurement, and/or to provide feedback to a user.
  • the attachment collar is intended for single use and the pressure sensor is used to enforce this.
  • the pressure sensor determines that the attachment collar has been placed on a patient, and then determines that it has been subsequently removed. Any subsequent attempts to reuse the sensor with the same attachment collar are prevented.
  • the two-piece sensor comprises an attachments collar 110 and a sensor 120.
  • the cable is clipped into a cable management system 130 to reduce cord pulls and provide strain relief.
  • Sidebars 140 secure sensor 120 to attachment collar 110, while pull tab 150 allows for easy removal of attachment collar 110 from the skin of the patient after use.
  • the two-piece sensor comprises an attachment collar 210 and a sensor 220.
  • Cable 230 is coupled to a controller that can send and receive information therebetween.
  • a selective adhesive 240 that secures sensor 220 to attachment collar 210.
  • the two-piece sensor comprises an attachment collar 310 and a sensor 320.
  • Cable 330 is coupled to a controller that can send and receive information therebetween.
  • a bar code 340 that is used to authenticate the combination of sensor 320 and attachment collar 310 thereby ensuring that a light-tight fit and secure attachment to the patient’s body surface is achieved.
  • cable management groove 350 to help reduce the opportunity for the cable to become caught and dislodged from the patient.
  • the two-piece sensor comprises an attachment collar 410 and a sensor 420. Also shown is one possible aspect of a light-tight connector 430 between sensor 420 and attachment collar 410. The non-linear surfaces of light-tight connector 430 reduces and/or eliminates extraneous light that may leak through between the interface of sensor 420 and attachment collar 410.
  • the two-piece sensor comprises an attachment collar 510 and a sensor 520. Also shown is one possible cam locking mechanism 530 that would secure sensor 520 to attachment collar 510. Sensor 520 would slidably connect tab 550 to slot 540 and then twist to secure the sensor in place ensuring that a secure attachment to the patient’s body surface is achieved. This locking mechanism would also be light-tight due to the nonlinear aspect of the male and female ends of the lock.
  • the two-piece sensor comprises an attachment collar 610 and a sensor 620.
  • Cable 630 is coupled to a controller that can send and receive information therebetween.
  • tabs 640 fit into slots 650 thereby ensuring proper alignment of sensor 620 with attachment collar 610 ensuring that a secure attachment and light-tight fit to the patient’s body is achieved.
  • the two-piece sensor comprises an attachment collar 710 and a sensor 720.
  • Cable 730 is coupled to a controller that can send and receive information therebetween.
  • attachment collar 710 is a stretchable pocket that includes an internal cavity 740 therein that receives sensor 720 ensuring a light-tight fit.
  • the two-piece sensor comprises an attachment collar 810 and a sensor 820.
  • Cable 830 is coupled to a controller that can send and receive information therebetween.
  • slot 840 could receive and secure cable 830 thereby reducing the incidence of cord-pull by the patient.
  • an RFID chip 850 that includes a security code that must be detected 860 by the sensor in order for the system to operate. This RFID code can be used for device security, for ensuring that a secure attachment and light-tight fit to the patient’s body is achieved, and for inventory control.
  • the two-piece sensor comprises an attachment collar 910 and a sensor 920.
  • Cable 930 is coupled to a controller that can send and receive information therebetween.
  • slots 940 are present to ensure a proper connection between sensor 920 and attachment collar 910.
  • the shape of the slots can be varied in the manner of a lock and key to ensure a secure attachment and as a form of fraud prevention and quality control.
  • the two-piece sensor comprises an attachment collar 1010 and a sensor 1020.
  • Cable 1030 is coupled to a controller that can send and receive information therebetween.
  • magnets 1040 are present to secure sensor 1020 to attachment collar 1010.
  • the two-piece sensor comprises an attachment collar 1110 and a sensor 1120.
  • Cable 1130 is coupled to a controller that can send and receive information therebetween.
  • cable clip 1140 is on attachment collar 1110 to secure cable 1130 to reduce or eliminate the incidence of cord-pull that would interfere with the use of the system.
  • the two-piece sensor comprises an attachment collar 1210 and a sensor 1220.
  • Attachment collar 1210 comprises an embedded chemical 1260 that is detected by sensor 1220 when properly placed to provide a secure connection.
  • Cord 1230 seats into slot 1240 thereby reducing movement and play in the cord.
  • identifier tab 1250 that is used to authenticate the attachment collar 1210 after detection by sensor 1220.
  • the two-piece sensor comprises an attachment collar 1310 and a sensor 1320.
  • Cable 1330 is coupled to a controller that can send and receive information therebetween.
  • sensor 1320 screws into attachment collar 1310 to provide a secure connection and light-tight interface between them.
  • the two-piece sensor comprises an attachment collar 1410 and a sensor 1420.
  • Cable 1430 is coupled to a controller that can send and receive information therebetween.
  • tab 1440 fits into slot 1450 to secure sensor 1420 to attachment collar 1410.
  • Cable 1430 fits into cable clip 1460 to secure the cable and reduce or eliminate the incidence of cord-pull that would interfere with the use of the system.
  • the two-piece sensor comprises an attachment collar 1510 and a sensor 1520.
  • Cable 1530 is coupled to a controller that can send and receive information therebetween.
  • tabs 1540 fit through slots 1550 on sensor 1520 and fold over 1560 to secure sensor 1520 to attachment collar 1510 ensuring that a secure attachment and light-tight fit to the patient’s body is achieved.
  • the two-piece sensor comprises an attachment collar 1610 and a sensor 1620.
  • the cable (not shown) is coupled to a controller that can send and receive information therebetween.
  • tabs 1630 would insert into holes 1640 thereby ensuring a secure connection between sensor 1620 and attachment collar 1610.
  • Holes 1640 could also be communication ports to send and receive information between sensor 1620 and attachment collar 1610 for both security and inventory purposes. This would eliminate the need for a wireless authentication thereby reducing the complexity and electronic components required in the overall system.
  • communication between sensor 1620 and attachment collar 1610 is via an EPROM type memory ensuring that a secure attachment and light-tight fit to the patient’s body is achieved.
  • the two-piece sensor comprises an attachment collar 1710 and a sensor 1720.
  • Cable 1730 is coupled to a controller that can send and receive information therebetween.
  • a cam-lock 1740 secures sensor 1720 to attachment collar 1710 after engaging locking arm 1750.
  • locking arm 1750 is engaged to secure sensor 1720, it also secures cable 1730 in a secure configuration 1760 ensuring that a secure attachment and light-tight fit to the patient’s body is achieved.
  • the two-piece sensor comprises an attachment collar 1810 and a sensor 1820.
  • Cable 1830 is coupled to a controller that can send and receive information therebetween.
  • Sensor 1820 is securely attached to attachment color 1810 via a strap 1840 that engages with tab 1850.
  • Engagement 1860 in some aspects, can be using Velcro, an adhesive, snap, buckle or other appropriate means ensuring that a secure attachment and light-tight fit to the patient’s body is achieved.
  • the two-piece sensor comprises an attachment collar 1910 and a sensor 1920.
  • the cable includes a cable management clip 1930 to secure the cord and reduce cord pulls and provide strain relief.
  • Side clips 1940 secure sensor 1920 to attachment collar 1910 while pull tab 1950 allows for easy removal from the skin of a patient after use.
  • the triangular shaped two-piece sensor comprises an attachment collar 2010 and a sensor 2020.
  • Cable 2040 clips into cable management system 2030 to reduce cord pulls and provide strain relief.
  • Pull table 2050 allows for easy removal from the skin of a patient after use.
  • the two-piece sensor comprises an attachment collar 2110 and a sensor 2120.
  • Cable 2130 wraps around skin sensor 2020 and clips into cable management system 2140 to reduce cord pulls and provide strain relief.
  • Pull table 2150 allows for easy removal from the skin of a patient after use.
  • the two-piece sensor comprises an attachment collar 2210 and a sensor 2220.
  • Sensor 2220 slides under side table 2250 on the attachment collar 2210 to secure the sensor in place.
  • Cable 2230 clips into cable management system 2240 to reduce cord pulls and provide strain relief.
  • Pull table 2150 allows for easy removal from the skin of a patient after use.
  • the attachment collar further comprises a means for securing the skin sensor to the at least one opening of the attachment collar as illustrated in Figures 1 to 22.
  • the two-piece sensor assembly further comprises a means for managing a cable attached thereto as illustrated in Figures 1 to 22.
  • the means for managing the cable is attached to the attachment collar, the skin sensor or both as illustrated in Figures 1 to 22.
  • the skin sensor and/or the attachment collar further comprises a means of authentication between the skin sensor and the attachment collar as described elsewhere herein.
  • Suitable indicator substances for use with the methods and devices described herein are disclosed in US 62/577,951, US 8,155,000, US 8,664,392, US 8,697,033, US 8,722,685, US 8,778,309, US 9,005,581, US 9,114,160, US 9,283,288, US 9,376,399, and US 9,480,687 which are all incorporated by reference in their entirety for all purposes.
  • the indicator substance is eliminated from the body of a patient by glomerular filtration.
  • the indicator substance is eliminated from the body of a patient only by glomerular filtration.
  • the indicator substance is a GFR agent.
  • the indicator substance is a pyrazine derivative of Formula I, or a pharmaceutically acceptable salt thereof,
  • (AA) comprises one or more amino acids selected from the group consisting of natural and unnatural amino acids, linked together by peptide or amide bonds and each instance of (AA) may be the same or different than each other instance;
  • PS is a sulfated or non-sulfated polysaccharide chain that includes one or more monosaccharide units connected by glycosidic linkages; and‘a’ is a number from 0 to 10,‘c’ is a number from 1 to 100, and each of‘m’ and‘n’ are independently a number from 1 to 3. In another aspect, ‘a’ is a number from 1 to 10. In still yet another aspect,‘a’ is 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10
  • (AA) comprises one or more natural or unnatural amino acids linked together by peptide or amide bonds.
  • the peptide chain (AA) may be a single amino acid, a homopolypeptide chain or a heteropolypeptide chain, and may be any appropriate length.
  • the natural or unnatural amino acid is an oc-amino acid.
  • the oc-amino acid is a D-oc-amino acid or an L-oc-amino acid.
  • each amino acid is selected independently of the other(s) in all aspects, including, but not limited to, the structure of the side chain and the stereochemistry.
  • the peptide chain may include 1 to 100 amino acid(s), 1 to 90 amino acid(s), 1 to 80 amino acid(s), 1 to 70 amino acid(s), 1 to 60 amino acid(s), 1 to 50 amino acid(s), 1 to 40 amino acid(s), 1 to 30 amino acid(s), 1 to 20 amino acid(s), or even 1 to 10 amino acid(s).
  • the peptide chain may include 1 to 100 oc-amino acid(s), 1 to 90 oc-amino acid(s), 1 to 80 oc- amino acid(s), 1 to 70 oc-amino acid(s), 1 to 60 oc-amino acid(s), 1 to 50 oc-amino acid(s), 1 to 40 oc-amino acid(s), 1 to 30 oc-amino acid(s), 1 to 20 oc-amino acid(s), or even 1 to 10 oc- amino acid(s).
  • the amino acid is selected from the group consisting of D-alanine, D-arginine D-asparagine, D-aspartic acid, D-cysteine, D-glutamic acid, D- glutamine, glycine, D-histidine, D-homoserine, D-isoleucine, D-leucine, D-lysine, D- methionine, D-phenylalanine, D-proline, D-serine, D-threonine, D-tryptophan, D-tyrosine, and D-valine.
  • the oc-amino acids of the peptide chain (AA) are selected from the group consisting of arginine, asparagine, aspartic acid, glutamic acid, glutamine, histidine, homoserine, lysine, and serine. In some embodiments, the oc-amino acids of the peptide chain (AA) are selected from the group consisting of aspartic acid, glutamic acid, homoserine and serine. In some embodiments, the peptide chain (AA) refers to a single amino acid (e.g., D-aspartic acid or D-serine).
  • (PS) is a sulfated or non-sulfated polysaccharide chain including one or more monosaccharide units connected by glycosidic linkages.
  • the polysaccharide chain (PS) may be any appropriate length.
  • the polysaccharide chain may include 1 to 100 monosaccharide unit(s), 1 to 90 monosaccharide unit(s), 1 to 80 monosaccharide unit(s), 1 to 70 monosaccharide unit(s), 1 to 60 monosaccharide unit(s), 1 to 50 monosaccharide unit(s), 1 to 40 monosaccharide unit(s), 1 to 30 monosaccharide unit(s), 1 to 20 monosaccharide unit(s), or even 1 to 10 monosaccharide unit(s).
  • the polysaccharide chain (PS) is a homopolysaccharide chain consisting of either pentose or hexose monosaccharide units. In other embodiments, the polysaccharide chain (PS) is a heteropolysaccharide chain consisting of one or both pentose and hexose monosaccharide units. In some embodiments, the monosaccharide units of the
  • polysaccharide chain are selected from the group consisting of glucose, fructose, mannose, xylose and ribose.
  • the polysaccharide chain (PS) refers to a single monosaccharide unit (e.g., either glucose or fructose).
  • the polysaccharide chain is an amino sugar where one or more of the hydroxy groups on the sugar has been replaced by an amine group. The connection to the carbonyl group can be either through the amine or a hydroxy group.
  • indicator substances include, but are not limited to, 3,6- diamino-N 2 ,N 2 ,N 5 ,N 5 -tetrakis(2-methoxyethyl)pyrazine-2, 5 -dicarboxamide, 3,6-diamino- N 2 ,N 5 -bis(2,3-dihydroxypropyl)pyrazine-2, 5-dicarboxamide, (2S,2'S)-2,2'-((3,6- diaminopyrazine-2,5-dicarbonyl)bis(azanediyl))bis(3-hydroxypropanoic acid), 3,6- bis(bis(2-methoxyethyl)amino)-N 2 ,N 2 ,N 5 ,N 5 -tetrakis(2-methoxy ethyl) pyrazine-2,5- dicarboxamide bis(TFA) salt, 3,6-diamino-N 2 ,N
  • the indicator substance is (2R,2'R)-2,2'-((3,6-diaminopyrazine-2,5- dicarbonyl)bis(azanediyl))bis(3-hydroxypropanoic acid) (also known as MB-102).
  • the indicator substance is (2S,2'S)-2,2'-((3,6-diaminopyrazine-2,5- dicarbonyl)bis(azanediyl))bis(3-hydroxypropanoic acid).
  • the indicator substance is (2R,2'R)-2,2'-((3,6-diamino-pyrazine-
  • the indicator substance is (2S,2'S)-2,2'-((3,6-diamino-pyrazine- 2,5-dicarbonyl)bis(azanediyl))bis(3-hydroxypropanoic acid) (also known as 3,6-diamino- N2,N5-bis(L-serine)-pyrazine-2, 5-dicarboxamide),
  • the indicator substance is selected from the group consisting of acridines, acridones, anthracenes, anthracylines, anthraquinones, azaazulenes, azo azulenes, benzenes, benzimidazoles, benzofurans, benzoindocarbocyanines, benzoindoles, benzothiophenes, carbazoles, coumarins, cyanines, dibenzofurans, dibenzothiophenes, dipyrrolo dyes, flavones, imidazoles, indocarbocyanines, indocyanines, indoles, isoindoles, isoquinobnes, naphthacenediones, naphthalenes, naphthoquinones, phenanthrenes, phenanthridines, phenanthridines, phenoselenazines, pheno
  • the indicator substance is any compound that is eliminated from the body of a patient by glomerular filtration. In still yet another aspect, the indicator substance is any compound that emits fluorescent energy when exposed to electromagnetic radiation and is eliminated from the body of the patient by glomerular filtration.
  • one or more atoms may alternatively be substituted with an isotopically labelled atom of the same element.
  • a hydrogen atom may be isotopically labelled with deuterium or tritium; a carbon atom may be isotopically labelled with 13 C or 14 C; a nitrogen atom may be isotopically labelled with 14 N or 15 N.
  • An isotopic label may be a stable isotope or may be an unstable isotope (i.e., radioactive).
  • the indicator substance may contain one or more isotopic labels.
  • the isotopic label may be partial or complete.
  • an indicator substance may be labeled with 50% deuterium thereby giving the molecule a signature that can be readily monitored by mass spectroscopy or other technique.
  • the indicator substance may be labeled with tritium thereby giving the molecule a radioactive signature that can be monitored both in vivo and ex vivo using techniques known in the art.
  • the indicator substance may be in the form of a pharmaceutically acceptable salt.
  • pharmaceutically acceptable salts include those as described by Berge, et al. in J. Pharm. Sci., 66(1), 1 (1977), which is incorporated by reference in its entirety for all purposes.
  • the salt may be cationic or anionic.
  • the counter ion for the pharmaceutically acceptable salt is selected from the group consisting of acetate, benzenesulfonate, benzoate, besylate, bicarbonate, bitartrate, bromide, calcium edetate, camsylate, carbonate, chloride, citrate, dihydrochloride, edetate, edisylate, estolate, esylate, fumarate, gluceptate, gluconate, glutamate, glycollylarsanilate, hexylresorcinate, hydrabamine, hydrobromide, hydrochloride, hydroxynaphthoate, iodide, isethionate, lactate, lactobionate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulfate, mucate, napsylate, nitrate, pamoate, pantothenate, phosphate, diphosphat
  • phenylethylbarbarbiturate picrate, propionate, thiocyanate, tosylate, undecanoate, benzathine, chloroprocaine, choline, diethanolamine, ethylenediamine, meglumine, procaine, benethamine, clemizole, diethylamine, piperazine, tromethamine, aluminum, calcium, lithium, magnesium, potassium, sodium zinc, barium and bismuth.
  • Any functional group in the indicator substance capable of forming a salt may optionally form one using methods known in the art.
  • amine hydrochloride salts may be formed by the addition of hydrochloric acid to the indicator substance.
  • Phosphate salts may be formed by the addition of a phosphate buffer to the indicator substance.
  • Any acid functionality present such as a sulfonic acid, a carboxylic acid, or a phosphonic acid, may be deprotonated with a suitable base and a salt formed.
  • an amine group may be protonated with an appropriate acid to form the amine salt.
  • the salt form may be singly charged, doubly charged or even triply charged, and when more than one counter ion is present, each counter ion may be the same or different than each of the others.
  • a method for determining a glomerular filtration rate (GFR) in a patient in need thereof generally comprises: applying a two-piece sensor assembly onto the body surface of the patient, administering into the body of the patient an indicator substance, said indicator substance configured to generate an optical response in response to an interrogation light; detecting said optical response using the two-piece sensor assembly over a predetermined period of time; and determining the GFR in said patient based on the detected optical response.
  • the two piece-sensor assembly is as described elsewhere herein.
  • the indicator substance is as described elsewhere herein.
  • the indicator substance is (2R,2'R)-2,2'-((3,6-diamino-pyrazine-2,5-dicarbonyl)bis-(azanediyl))bis(3- hydroxypropanoic acid) (also known as MB-102 or 3,6-diamino-N2,N5-bis(D-serine)- pyrazine-2, 5 -dicarboxamide),

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Abstract

La présente invention concerne un ensemble capteur en deux parties qui comprend un collier de fixation configuré pour être fixé à une surface corporelle d'un patient et comprenant au moins une ouverture, et un capteur cutané configuré pour être placé dans la ou les ouvertures dans le collier de fixation. Le capteur cutané comprend au moins une source de rayonnement configurée pour irradier la surface corporelle avec au moins une lumière d'interrogation, et au moins un détecteur configuré pour détecter au moins une lumière de réponse incidente à partir de la direction de la surface corporelle.
EP19910336.7A 2019-01-16 2019-08-27 Ensemble capteur en deux parties et procédé d'utilisation Pending EP3911217A4 (fr)

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AU2019423269A1 (en) 2021-07-29
JP2022524697A (ja) 2022-05-10
US11261165B2 (en) 2022-03-01
CN111436947A (zh) 2020-07-24
US20220153708A1 (en) 2022-05-19
KR20210124215A (ko) 2021-10-14
WO2020149885A1 (fr) 2020-07-23
BR112021013103A2 (pt) 2021-11-23
EP3911217A4 (fr) 2022-10-05
IL284886A (en) 2021-08-31
ZA202104473B (en) 2023-03-29
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JP7532380B2 (ja) 2024-08-13
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